Speculum instrument with disposable forward section

ABSTRACT

Speculum instrument for use with disposable plastic (polyethylene) sigmoidoscope or proctoscope tube. The elongated tubes are tapered to provision for the geometric optics employed, and contain a light shield, which acts to diffuse the light source and also protect the light source and instrument from contamination The tubes contain a rectangular groove that provides for its captivation by the instrument. A disposable plastic obturator is also provided with each tube. The instrument is fitted with a cylindrical lamp holder assembly having a plurality of lamps, an eye piece that allows one to look through the cylinder of lamps, a spring retaining ring that provides for the colleting of the disposable tubes, a cam push button arrangement for opening the retaining ring collet and ejecting the disposable tube, a handle that contains a rechargeable battery, a reostat with thumb wheel which controls the amount of light, a fitting for rubber tubing to allow for the admission of air, an air valve for the release of air, and gasket seals to provide for an air tight assembly.

United States Patent Saslow et al.

[ Dec. 18, 1973 I 1 SPECULUM INSTRUMENT WITH DISPOSABLE FORWARD SECTION[73] Assignee: Espey Mfg. & Electronics Corp.,

Saratoga Springs, NY.

[22] Filed: Sept. 30, 1971 [21] App]. No.: 185,138

[52] US. Cl 128/6, 285/39, 285/321 [51] Int. Cl A611) l/06, F16] 35/00,F16155/00 [58] Field of Search 128/6; 285/39, 321, 285/331 [5 6]References Cited UNITED STATES PATENTS 1,849,701 3/1932 Allyn 128/62,040,155 5/1936 Shoemaker.. 285/39 3,032,031 5/1962 Moore 128/63,127,115 3/1964 Yellott et al. 128/6 UX 3,373,736 3/1968 Fiore et al.128/6 3,521,911 7/1970 Hanes et a1. 284/39 X 3,544,140 12/1970Langcheck.... 285/321 3,616,792 11/1971 Pleet 128/16 3,090,379 5/1963Ferris.... 128/6 3,426,663 2/1969 Fox 128/6 X FOREIGN PATENTS ORAPPLICATIONS 1,333,552 6/1963 France 285/321 84,847 3/1965 France 128/6OTHER PUBLICATIONS New Visiline* Disposable Sigmoidoscopes."Advertisement of Smith Kline Instr. Co. In. Surg., Gyn. and Obs. 12048-49. 1965.

Hirschowitz, Basil 1., Endoscopic Examination of the Stomach andDuodenal Cap With The Fiberscope." In Lancet, May 20, 1961, pp. 1074.

Primary Examiner-Channing L. Pace Attorney-George B. Oujevolk [57]ABSTRACT Speculum instrument for use with disposable plastic(polyethylene) sigmoidoscope or proctoscope tube. The elongated tubesare tapered to provision for the geometric optics employed, and containa light shield, which acts to diffuse the light source and also protectthe light source and instrument from cantamination. The tubes contain arectangular groove that provides for its captivation by the instrument.A disposable plastic obturator is also provided with each tube. Theinstrument is fitted with a cylindrical lamp holder assembly having aplurality of lamps, an eye piece that allows one to look through thecylinder of lamps, a spring retaining ring that provides for thecolleting of the disposable tubes, a cam push button arrangement foropening the retaining ring collet and ejecting the disposable tube, ahandle that contains a rechargeable battery, a reostat with thumb wheelwhich controls the amount of light, a fitting for rubber tubing to allowfor the admission of air, an air valve for the release of air, andgasket seals to provide for an air tight assembly.

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SPECULUM INSTRUMENT WITH DISPOSABLE FORWARD SECTION BACKGROUND OF THEINVENTION The present invention relates to speculum instruments havingrapid, easy coupling and releasing means for a disposable forwardsection, either sigmoidscope or proctoscope and more particularly, acordless speculum instrument having a contamination free lightingarrangement.

DESCRIPTION OF THE PRIOR ART Speculum instruments may be defined broadlyas instruments adaptable for insertion into a body opening, human oranimal, in order to medically observe or treat an inner portion. Inparticular, rectal speculum instruments, which generally includeproctoscopes, anoscopes and sigmoidoscope, have become increasinglyimportant in routine and preventative medical examinations, as well asfor medical treatment. More specifically, there is increased use ofsigmoidoscope for examination and treatment of the upper reaches of thecolon in conjunction with the early diagnosis of cancer and treatmentthereof. The ease of use of the speculum instrument together with goodillumination are highly desirable for this purpose.

Instruments of this type have been produced using fiber optics forillumination. These have various shortcomings. One, because of thebrittle nature of the plastic employed, it can crack and shatter in afashion similar to glass. Secondly, it does not present a uniform lightfield, leaving a dark spot in the center. Another problem has been thatof the electric cord. Assistants have tripped over the cord causingcomplications. There has been considerable controversy with regard tothe light source; in view of this situation, some authorities evensuggest that a light source should be external to the instrument. It isquite apparent that a onepiece instrument is better than a two pieceinstrument and what is required is a light source which is part of theinstrument, but which is readily controllable and which will be externalto the patient. Heretofore, a light source near the end of theinstrument would suffice for short-length speculum devices whererelatively low lighting levels are sufficient. However, in the longerspeculum instruments, such as a sigmoidoscope, where the effectivelength may be on the order of centimeters and where the instrument is ofnecessity an enclosing cylinder, more lighting is necessary because ofthe distance involved and the inverse square law relationship forillumination.

Because of this situation it is usual design practice in sigmoidoscopeto have the light source placed inside the cylindrical tube adjacent theforward end. In this position, however, the light source is subject tocontamination from contact with the patient, impeding reuse for otherpatients without intervening cleansing. Therefore, the highly desirabledisposability concept of the sigmoidoscope is limited by its beingcombined and employed with a lighting means which is not disposable orimmediately reusable.

Another problem associated with the above described and other lightingmeans incorporated with the speculum relates to the ease of assembly anddetachability of the disposable parts from the lighting means withoutdisturbing or contaminating the light source. A further problem withproctoscopic devices employing an obturator relates to provision forremoving the obturator while the lighting means is in position withoutsubsequent reassembly of component parts.

SUMMARY OF THE INVENTION Generally speaking, the present inventioncontemplates an optical medical instrument for use with a single usedisposable plastic speculum and obturator. The instrument handle hasspace for the insertion of a rechargeable battery, and contains areostat with a thumb wheel which controls the reostat. The instrumenthouses a cylindrical lamp holder having a plurality of lamps. Theselamps are connected in parallel with each other and in series with thebattery, reostat and thumb wheel control. The lamp assembly is fittedwith electrical pin connections which mate up with receptacles in thehandle. The lamp assembly can be easily removed for replacement at endof life of the lamps. In line with the axis of the speculum and behindthe lamp cylinder assembly is an eye piece which can swing out of theway for removal of the obturator or to allow for the introduction of asuction catheter during the examination. The eye piece is fitted withprecision optics to allow for variation in the examiners vision andprovide an optimal depth of field at the distant position of thespeculum. Interchangeable lenses are available for different specula.The instrument is fitted with a spring retaining ring which captivatesthe disposable speculum while also making an air pressure tight sealbetween the speculum and the instrument. The eye piece is also fittedwith an O-ring to provide an air seal when it is swung into the closedposition. An air fitting is provided on the body of the instrument forconnecting a rubber tube and air bag to allow air to be pumped into thebarrel of the tube during examination. An air release valve is alsoaffixed to the body of the instrument to control the release of airduring examination.

The invention, as well as other objects and advantages thereof, willbecome more readily apparent from the following detailed descriptionwhen taken together with the accompanying drawings in which:

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective and partlyexploded view of some of the components used in the inventive concept;

FIG. 2 shows another perspective view of some of the components usedin'the inventive concept;

FIG. 3, likewise presents in a perspective view, components contemplatedherein;

FIG. 4 is a partly exploded and perspective explanation of most of thecomponents of the device contemplated herein;

FIG. 5 is a schematic diagram of the electric circuitry used herein;

FIG. 6 is a cross-sectional view of the optical train contemplated;

FIG. 7 is a sectional view of a portion of the instrument explaining theunion of the disposable part thereto;

FIG. 8 is a perspective view of the union components;

FIG. 9 is a side view of the release mechanism; and,

FIG. 10 is a sectional view of the union of the disposable part to theinstrument.

DETAILED DESCRIPTION Shown in the drawing is an elongated handle 11serving as the battery housing. Handle 11 having a trapezoidalcross-section has a'lower portion 13 which will contain a rechargeablebattery assembly 17. The battery contained in assembly 17 consists ofcommercially available rechargeable nickel-cadmium sealed cellsavailable from various companies under various trademarks, e. g., G.E.Batteries, Marathon Batteries. Battery assembly 17 fits into handle 11when inserted from the lower portion 13 and electrical contact is madeby means of miniature pin jacks. The battery assembly is retained in theinstrument handle by two machine screws. At the upper portion of theinstrument handle is an opening 19 to receive a holder 21 for thereostat and thumb wheel 23 which moves the reostat contact. Thus, byturning the thumb wheel, the lamps can be switched from off to on andthe current through the lamps and thereby their intensity can becontrolled. The upper portion of the drawing shows the cylindrical head25 of the instrument which houses the cylindrical lamp holder assembly27 at the front and has an eye piece holder 29 at the rear. Lamp holderassembly 27 consists of hollow metal cylinder with a thick cylindricalwall 31. Eight lamps 33 are disposed within this wall. At the inner endof the lamp holder unit is a printed circuit board (shown schematicallyin FIG. which connects the miniature lamps in parallel and terminates intwo conductor pin plugs. The cylinder contains a guide key 30, and fitssnugly within the cylindrical head of the instrument while engaging twomating pin connectors. The miniature lamps contain lenses to concentratethe light in the forward direction of the instrument. The polished metalwalls around the lamps act as reflectors and scatter the light in theforward direction of the instrument. The lamp holder assembly is kept inthe instrument head 25 at all times in normal use and'is only removedfor replacement in case of lamp failure or end of life of the lamps. Asis customary in this type of instrument, an air fitting nipple 47 isattached to the head 25. An air release valve 53 is also attached to theinstrument head 25. A retaining ring 63 is located at the front face ofthe instrument head and acts as a collet when holding and receiving tube41. Directly behind retaining ring 63 is rubber pad 65 which iscompressed and forms an air seal with the insertion of tube 41 againstthe edge 67 when it is retained in groove 69. Release button 55 isconnected to cam activator 71 which when depressed works against thespring action of the retaining ring 63 to release it from the groove inthe tube and thence pushing on the tube wall 73 to eject the tube 41from the instrument.

This arrangement is shown in FIGS. 7 to 10. As is evident, it isnecessary to quickly release the disposable tube barrel 41 from theinstrument head 25. On the inner end of the barrel 41 is an outer groove69 and on the inner portion of the head 25 is a corresponding groove69a, as shown in FIG. 7. Now, as shown in FIG. 7, the inner edge 67 ofthe barrel 41 can slide into the head 25 because of the taper 67a beforethe inner edge 67. Just past the taper 67a is barrel groove 69, whichwhen the taper 67a is pushed into the head will be oppositecorresponding groove 69a. Within groove 69a is ring 63, better shown inFIG. 9. This ring has an enlarged bottom horseshoe section 63a. Whenrelease button 55 is pushed, the cam activator 71 will enter thehorseshoe section 63a opening the ring so that it does not enter groove69. However, when the release button is not depressed, the ring assumesthe position shown in FIG. 10, engaging both grooves 69 and 69a, so asto hold the barrel 41 to the head 25. Because of the taper 67a, it isusually possible for the barrel to be inserted into the head withoutpressing the release button. However, when the ring has engaged groove69, the barrel will not be separated from the head unless the releasebutton is pressed.

Thus, cam activator 71 centers and opens the retaining ring 63 and canalso be used when inserting the disposable barrel 41 in the head to aidin the operation. When groove 69 coincides with groove 69a the ringsnaps into groove 69 and latches the disposable barrel into position.Therubber pad 65 is depressed at this point and provides a seal. Todisconnect the union, the release button 55 is pressed causing camactivator 71 to slide through the horseshoe section 63a which opens thering so as to eject the disposable barrel. The ejector is returned toits original position by the spring properties of the ring reactingagainst cam activator 71.

Eye piece holder 29 is hinged to the instrument head 25 at the rear atan angle of 30 with the horizontal. An O-ring 75 is contained in the eyepiece holder to provide an air seal when the eye piece holder 29 is in aclosed position and retained by latch 77. The eye piece holder 29 isfitted with a clear lens to permit viewing through the instrument andalso effect the air seal when the eye piece holder is latched closed.The eye piece holder 29 is further provisioned to accept a screw onviewer which is comprised of a concave and convex lens to form aGalalian telescope 78 (FIG. 6).

The plastic disposable parts that are used in conjunction with theinstrument consist of the sigmoidoscope tube which has a barrel 41, thatextends for 25 centimeters and is marked with graduations incentimeters. It has a matching obturator 37 which is a separate part andalso made of high density polyethylene. The plastic is opaque and iscolored torquoise. In the case of a proctoscope the barrel lengthextends for 15 centimeters instead of 25 centimeters. The disposabletube has a hexagonal front face 73 for rotational orientation andhandling and a tapered end which contains the captivation groove 69 andsealing edge 67. The light shield 39 is a part of the disposablesigmoidoscope tube and is captivated within the hollow portion at aposition approximately in line with the front face 73. The light shield39 is comprised of an opaque plastic hollow thin wall tube fitted to asemi-transparent plastic washer 79. When installed in the instrumentwith a sigmoidoscope tube the hollow tube of the light shield 39 extendsall the way up to the eye piece holder 29 and the semitransparentplastic washer 79 is up against the lamp assembly 27 so as to isolatethe instrument from the patient by means of the disposable parts. Alsoused in conjunction with the instrument is a hand air pump whichcontains air bag 51 and rubber tube 49 which gets attached to theinstrument air nipple 47. The air bag and tube are commerciallyavailable and indeed interchangeable with those used on other medicalinstruments.

OPERATION OF THE INSTRUMENT When the instrument is not in use it isinserted into the well of the battery charger, such as described incopending patent application entitled Battery Charger," Ser. No.174,611, filed on Aug. 25, 1971. The charger is fitted with matching pinjacks to make electrical connection to the rechargeable batteryconnectors contained in the handle of the instrument 15. The chargerrestores the electrical energy to the battery immediately after use andmakes the instrument rapidly available for reuse.

The instrument is usually prepared for use by a nurse.

and the instrument is again ready for use.

We claim: 1. A speculum instrument including an extended handle unit forholding a barrel, comprising in combina- The obturator 37 is normallyfurnished in the barrel of 5 ti the tube 41. A lubricant is generallyapplied at the tip 59 of the obturator 37. The instrument is removedfrom the battery charger and the eye piece holder 29 is unlatched andleft open. The sigmoidoscope and obturator are then inserted from thefront end of the instrument through the hole in the lamp assembly 27 sothat the handle of the obturator 57 extends outside the rear of theinstrument at the eye piece holder 29. The tube is pushed inward in theinstrument which expands the retaining ring 63 because of the taper ofthe tube wall between edge 67 and the surface 73 until the retainingring reaches groove 69 which allows the retaining ring 63 to collapseand thus captivates the tube in the instrument. The instrument is nowready for use by the physician who generally performs his examination ina darkened examination area. Entrance to the body cavity is first madewith the obturator forward in the tube with the tip 59 protruding. Afteraccess has been achieved past the anus the obturator is removed throughthe rear of the instrument and discarded. The eye piece holder 29 isthen swung shut and the thumb wheel 23 rotated turning the lamps 33 on.The thumb wheel 23 is adjusted to give the desired amount of light. Thesigmoidoscope tube 41 is progressively advanced while observing throughthe eye piece. Air is introduced as desired by means of the hand pump 40and released by means of the release valve 53 to expand the bowel infront of the tube end. The location of the diagnosis is recorded basedon the orientation of the instrument tube in relation to the patientsnormal position using the numbers of the face of a clock as referenceand the depth of insertion by the distance in centimeters that the tubehas been inserted, i.e., 2 oclock l0 centimeters.

It may be necessary during the examination to remove a small amount offluid (usually less than a tea spoon full) that has remained in thecolon. This is done when the fluid can be seen by opening the eye pieceholder door 29 and introducing a suction catheter which is connected toa vacuum line. After the fluid has been removed the eye piece holder 29is shut and the examination continued. At the completion of theexamination the tube is carefully withdrawn and the sigmoidoscope tubeis discarded by pushing the release button. The instrument is theninserted in the battery charger which restores the consumed energy tothe battery a. a hollow cylindrical head at one end of said handleintroducing an eye piece pivotally attached thereto;

b. a hollow cylindrical lamp holder unit held in said head, said handlehaving a thick cylindrical outer wall with lamp holding places definedin said wall holding a plurality of lamps so as to reflect their lightin a direction substantially normal to said extended handle;

c. a rheostat and thumb wheel control unit removably held at the part ofsaid handle adjacent said head;

(1. a battery space between said unit and said handle other endincluding means holding a rechargeable battery in said handle, meansconnecting said battery to said lamps through said rheostat unit; and,

e. a disposable plastic elongated barrel including a tapered collectingsleeve for latching onto said cy lindrical head, said head and saidbarrel having corresponding circular grooves, a split resilient ringband in said head for engaging said grooves, said ring band having aradially extending enlarged split section, and plunger release means forpressing into the split at said enlarged split section across said headto release said barrel from said head.

2. The instrument as claimed in claim 1, said grooves being an outergroove on said barrel and an inner groove on said head, said enlargedsection having two wide open portions on each side of said split, saidre lease means, including a cam with a tapered end penetrating said openportions widening said ring so as to effectuate said release.

3. The instrument as claimed in claim 2, said release means furthercomprising a plunger release button in said head, a plunger rodconnected to said button, said rod in turn being connected to said camwhich is so disposed that the tapered end will penetrate said wide openportions on each side of said slit, the pressing on said button causingsaid cam to penetrate said slot.

4. The instrument as claimed in claim 3, wherein said barrel is made ofpolyethylene and has graduations on the outside thereof.

5. The instrument as claimed in claim 4, including a removable elongatedobturator which can be removed from said head when said eye piece ispivotally open.

1. A speculum instrument including an extended handle unit for holding abarrel, comprising in combination: a. a hollow cylindrical head at oneend of said handle introducing an eye piece pivotally attached thereto;b. a hollow cylindrical lamp holder unit held in said head, said handlehaving a thick cylindrical outer wall with lamp holding places definedin said wall holding a plurality of lamps so as to reflect their lightin a direction substantially normal to said extended handle; c. arheostat and thumb wheel control unit removably held at the part of saidhandle adjacent said head; d. a battery space between said unit and saidhandle other end including means holding a rechargeable battery in saidhandle, means connecting said battery to said lamps through saidrheostat unit; and, e. a disposable plastic elongated barrel including atapered collecting sleeve for latching onto said cylindrical head, saidhead and said barrel having corresponding circular grooves, a splitresilient ring band in said head for engaging said grooves, said ringband having a radially extending enlarged split section, and plungerrelease means for pressing into the split at said enlarged splIt sectionacross said head to release said barrel from said head.
 2. Theinstrument as claimed in claim 1, said grooves being an outer groove onsaid barrel and an inner groove on said head, said enlarged sectionhaving two wide open portions on each side of said split, said releasemeans, including a cam with a tapered end penetrating said open portionswidening said ring so as to effectuate said release.
 3. The instrumentas claimed in claim 2, said release means further comprising a plungerrelease button in said head, a plunger rod connected to said button,said rod in turn being connected to said cam which is so disposed thatthe tapered end will penetrate said wide open portions on each side ofsaid slit, the pressing on said button causing said cam to penetratesaid slot.
 4. The instrument as claimed in claim 3, wherein said barrelis made of polyethylene and has graduations on the outside thereof. 5.The instrument as claimed in claim 4, including a removable elongatedobturator which can be removed from said head when said eye piece ispivotally open.